Our View: FDA should first do no harm, stop Zohydro from entering market

The Food and Drug Administration was set up to act as a safeguard between modern-day snake oil salesmen and the general public. Most people do not have the background or means to verify the safety and effectiveness of medication, so it became the responsibility of government to do so. But the FDA appears to have shirked that responsibility by approving Zohydro, a powerful new painkiller set for release next month.

The Food and Drug Administration was set up to act as a safeguard between modern-day snake oil salesmen and the general public. Most people do not have the background or means to verify the safety and effectiveness of medication, so it became the responsibility of government to do so. But the FDA appears to have shirked that responsibility by approving Zohydro, a powerful new painkiller set for release next month.

Zohydro is a more powerful version of the second-most-abused prescribed medicine in the country. It contains hydrocodone, a highly addictive painkiller. The major difference between Zohydro and other painkillers that use hydrocodone, such as Vicodin, is that Zohydro is pure hydrocodone, which is highly addictive.

Zohydro is also a time-release medication. That makes it similar to OxyContin, which has been one of the most abused prescribed substances for much of the past decade, in part because it could be crushed, then snorted or injected. In response to public pressure, OxyContin was reformulated several years ago to make it “abuse resistant.” The makers of Zohydro say they also plan to make it crush-resistant, but not for several years.

Because of its potency, the risk of accidental overdoses is as worrisome as the risk of abuse. A small child could die from swallowing just one pill, experts say.

The FDA’s own advisory committee apparently recognized the dangers before it overwhelmingly recommended against its approval. In October, the FDA ignored the committee and approved the drug.

Opposition to the FDA’s move has been growing. U.S. Rep. William Keating condemned the FDA approval. “Just as the FDA was making some steps forward in the fight to end prescription drug abuse, they take major steps back with the approval of Zohydro ER,” he said. “Last year ... FDA not only approved this dangerous drug, but did so without requiring any abuse-deterrent features. This is outrageous.”

Keating said prescription drug abuse is the fastest growing drug problem in America. “I fear that with the approval of Zohydro ER, we will most definitely see a continued rise in abuse ... .”

The pharmaceutical industry, not surprisingly, has produced studies and reports showing the need for more effective painkillers, such as Zohydro. The market for legal painkillers has been estimated as high as $10 billion a year, so we can see why a company would fight for market share by marketing a new, stronger product. That doesn’t make it in the public interest to approve a drug of dubious medical necessity.

Hippocrates is believed to be the originator of the sentiment that has guided doctors and their ilk for centuries: First do not harm. The FDA would do well to consider that principle before it allows Zohydro ER on the market.